Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

NCT05759481 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00021935
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.

Conditions

Post-operative Nausea and Vomiting

Keywords

Post-Operative Nausea; Post-Operative Vomiting; propofol; motion sickness

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV)

  Postoperative nausea and vomiting (PONV) within 24 hours was defined as any episode of nausea, retching, or vomiting occurring from PACU discharge up to 24 hours after surgery. Data were collected using standardized patient questionnaires and follow-up telephone interviews conducted at 24 hours after surgery.

  24 hours

Secondary Outcomes (2)

• Episodes of Post Operative Nausea/Vomiting (PONV)

  PACU

• Use of Antiemetics

  24 hours

Other Outcomes (14)

• Number of Subjects Experiencing Nausea.

  PACU upto 23 hrs.

• Number of Subjects Experiencing Retching.

  PACU upto 23 hrs

• Vomiting (Forceful Expulsion of Gastric Contents) Episodes

  24 hours

Study Arms (2)

Hybrid anesthesia (propofol + sevoflurane)

ACTIVE COMPARATOR

Participants received general anesthesia maintained with a continuous low-dose propofol infusion combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered.

Drug: Hybrid anesthesia (propofol + sevoflurane)

Propofol only TIVA

ACTIVE COMPARATOR

Participants received general anesthesia maintained with propofol-based total intravenous anesthesia (TIVA). Propofol infusion was titrated to maintain a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered

Drug: Propofol only TIVA

Interventions

Hybrid anesthesia (propofol + sevoflurane) DRUG

General anesthesia maintained with a continuous low-dose propofol infusion (25 mcg/kg/min) combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted.

Hybrid anesthesia (propofol + sevoflurane)

Propofol only TIVA DRUG

General anesthesia maintained exclusively with intravenous propofol infusion, without the use of volatile anesthetics. Propofol dosing was titrated to maintain a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted

Propofol only TIVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing general anesthesia for elective surgery
• Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
• No documented allergy/adverse reaction to propofol
• English speaking
• At least 18 years of age

You may not qualify if:

• Any anti-nausea medication taken within 24 hours prior to surgery
• Unable to provide consent independently
• Allergy or adverse reaction to propofol
• Emergency surgery

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Keck WL, Deng E, Liu WM, Kanekar R, Lomivorotov V, Sharma S. Effect of low-dose propofol infusion with sevoflurane versus propofol-only total intravenous anesthesia on postoperative nausea and vomiting in high-risk patients: a single-blind randomized controlled clinical trial. BMC Anesthesiol. 2026 Jan 28;26(1):136. doi: 10.1186/s12871-026-03649-7.

  PMID: 41593496 DERIVED

MeSH Terms

Conditions

Vomiting; Motion Sickness

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Dr Revati Kanekar, Assistant Professor, Dept of Anesthesiology and Perioperative Medicine
• Organization: Penn State Milton S Hershey Medical Center

rkanekar@pennstatehealth.psu.edu

7175310000

Study Officials

• Sonal Sharma, MD

  Assistant Professor, Department of Anesthesiology and Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 8, 2023
• Study Start: February 1, 2024
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: August 14, 2026
• Results First Posted: August 14, 2026

Record last verified: 2026-08

Locations

US (1)